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Clinical Trial Summary

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.


Clinical Trial Description

It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.

Primary objective

- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

Secondary objectives

- Improvement of respiratory performance.

- Improvement of acute phase inflammation indices.

- Evaluation of known adverse events related to the use of the drug.

- Evaluation of the epidemiological parameters in COVID-19 patients.

- Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives

- Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients. ;


Study Design


Related Conditions & MeSH terms

  • Coronavirus Infections
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Syndrome

NCT number NCT04361903
Study type Observational
Source Azienda USL Toscana Nord Ovest
Contact Enrico Dr Capochiani, hematologist
Phone 00393473527340
Email enrico.capochiani@uslnordovest.toscana.it
Status Not yet recruiting
Phase
Start date April 25, 2020
Completion date May 31, 2020

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